BACKGROUND OF THE INVENTION
[0001] The present invention relates to an apparatus for hemo(dia)filtration.
[0002] Specifically, though not exclusively, the invention can be usefully applied for realising
a disposable fluid circuit associable to a machine for on-line preparation of a dialysis
fluid with the aim of performing a hemo(dia)filtration treatment.
[0003] As is known, a hemo(dia)filtration treatment comprises stages of creating an extracorporeal
circulation of a patient's blood, of passing the extracorporeal blood internally of
a hemo(dia)filter having a semipermeable membrane, of ultrafiltering a part of the
plasmatic liquid contained in the extracorporeal blood through the semipermeable membrane,
and of introducing a replacement fluid into the extracorporeal blood before (pre-dilution)
and after (post-dilution) the hemo(dia)filter. The quantity of replacement fluid introduced
is equal to the quantity of ultrafiltered plasmatic liquid, minus the desired weight
loss of the patient.
[0004] In particular the present invention relates to an apparatus comprising an extracorporeal
blood circuit having an arterial line (which takes the extracorporeal blood from the
patient to the hemo(dia)filter) and a venous line (which returns the blood from the
hemo(dia)filter to the patient), a replacement liquid supply line for the extracorporeal
blood circuit, a bifurcation dividing a main line of the supply line into a pre-dilution
line connected fluidly to the arterial line and a post-dilution line connected fluidly
to the venous line, a tube pump tract, in the form of an open ring and predisposed
in the supply line for coupling with a replacement liquid fluid circulation line,
and an expansion chamber predisposed in the extracorporeal blood circuit and fluidly
connected to the predilution branch and the post-dilution branch.
[0005] An apparatus made in this way is known, for example, in
US 2005/0131331, which describes a medical fluid circuit unit for a hemodiafiltration treatment comprising:
a fluid transport line having an inlet end predisposed for removable connection with
an on-line preparation circuit of a dialysis fluid; a pump tract predisposed for coupling
with a peristaltic pump for dialysis fluid circulation; an ultrafilter fluidly inserted
in the transport line for the dialysis fluid ultrafiltration with the aim of making
it suitable for infusion in an extracorporeal blood circuit as a replacement fluid;
and a bifurcation in which the transport line divides downstream of the ultrafilter
in a pre-dilution line, connected to the blood circuit upstream of a hemodiafilter,
and a post-dilution line, connected to the blood circuit downstream of the hemodiafilter.
[0006] Italian patent
IT 1222122 illustrates, in figure 3, an integrated module for hemodiafiltration constituted:
by a chamber 1 for pre-pump arterial pressure monitoring in which the blood coming
from the patient enters, provided with an attachment 2 for monitoring the pressure,
an attachment 3 for a service line, an attachment point 4 for connecting to the patient,
and an attachment point 5 to the arterial pump tube tract; by an arterial post-pump
expansion chamber 6, connected to the pre-pump chamber by the pump tube, external
of the module and subjected to the action of the arterial blood pump, and from which
the blood is sent to the hemodiafilter, provided with an attachment point 7 for the
arterial pump tube tract, an attachment 3 for a service line, an anticoagulant infusion
point 8 and an attachment point 9 for connection with the dialyser; by a monitoring
chamber 10 of the venous pressure, to which the purified blood from the hemodiafilter
and a replacement fluid flow, the monitoring chamber 10 being provided with a filter
11, an attachment for a service line, an attachment point 12 of the connection in
exit from the dialyser, an attachment point 13 for connection with the replacement
fluid infusion, and an attachment point 20 for the infusion pump tube; by a control
chamber 17 of the replacement fluid coming from one or more bags and connected to
the venous chamber 10 by a pump tube subjected to the action of a peristaltic pump,
provided with an attachment 3 for a service line, an attachment point 18 of the connection
with the replacement bag solution, and an attachment point 19 for the infusion pump
tube tract. The integrated module can be made of any thermoplastic material suitable
for use in the biomedical field for contact with blood, either rigid or semi-rigid,
for example polyvinyl chloride, polycarbonates etc.
[0007] US 4666598 describes an extracorporeal blood circuit provided with: a cartridge including an
arterial blood chamber and a venous blood chamber; a first arterial branch having
a flexible tube with a first end designed for connection with a vascular access of
a patient and with a second end connected to an inlet of the arterial chamber; a pump
tract formed by a flexible ring-shaped tube which extends from one side of the cartridge
and has a first end connected to an outlet of the arterial chamber and a second end
connected to a blood passage conduit internal of the cartridge; a second arterial
branch having a flexible tube with a first end connected to the blood passage conduit
and a second end designed for connection to an inlet of a membrane blood treatment
device (dialyser); a first venous branch having a flexible tube with a first end designed
for connection with the membrane blood treatment device and with a second end connected
to an inlet of the venous chamber; a second venous branch having a flexible tube with
a first end connected to an outlet of the venous chamber and a second end designed
for connection to the vascular access of the patient. The cartridge exhibits three
projections for mounting to the front panel of a dialysis machine, in which two projections
are formed by two tubular extensions with parallel axes, arranged one above the other
on aside of the cartridge adjacent to the arterial chamber, and a third projection
arranged on the opposite side of the cartridge, adjacent to the venous chamber. The
cartridge is placed in a work configuration by coupling each projection with a respective
clip, arranged on the panel of the dialysis machine.
[0008] US 5441636 describes an integrated blood treatment module comprising a support element in the
form of a quadrilateral plate bearing on each side thereof four open-ring shaped pump
tracts, projecting towards the outside of the periphery of the support element and
designed for coupling with respective peristaltic pumps, and a device for membrane
blood treatment (dialyser) fixed to the centre of the support element and having a
blood chamber, fluidly connected to a pump tract for blood circulation, a fluid chamber
fluidly connected to a pump tract for circulation of fresh dialysis liquid and a pump
tract for circulation of exhausted dialysis liquid, and a semipermeable membrane which
separates the blood chamber from the fluid chamber. The support element is mounted
on a blood treatment apparatus by means of four elastic engagement fingers which extend
from the front panel of the apparatus and which snap into openings afforded in the
support element at opposite sides of the membrane blood treatment device.
[0009] WO 2004/004807 describes a circuit for infusion of a medical fluid in an extracorporeal blood circuit,
comprising: a fluid transport line connected with a bag of medical fluid to be infused
into the extracorporeal blood circuit; a flat support element having two tubular extensions
to which the two ends of an open-ring pump tract are connected, the pump tract being
predisposed for coupling with a peristaltic pump for circulation of the medical fluid;
and a double-membrane air separator arranged fluidly downstream of the pump tract
and integrated with the support element. The air separator comprises a hydrophilic
membrane which holds back the gaseous component of the medical fluid and a hydrophobic
membrane arranged in a breather for evacuation of the gaseous component. The support
element exhibits at the centre thereof a through-opening which is used for mounting
the element on a panel of a medical apparatus provided with the peristaltic pump.
[0010] Italian patent
IT 1276447 describes a blood line which forms an integrated unit comprising an arterial line
and a venous line connected to one another at a drip chamber belonging to the venous
line. The drip chamber is formed by a container that is superiorly closed by a cap.
A through-hole is afforded internally of the cap, which through-hole belongs to the
arterial line and exhibits at the ends thereof connections for tracts of tube of the
arterial line. One of these connections is fixed at an end of an arterial pump tract,
the other end of which is fixed to a connection and support element which is fixed
to the outside of the container and which is further connected fluidly to a patient
tract of the arterial line.
[0011] US 4436620 describes an integral hydraulic circuit for a hemodialysis apparatus which comprises
a rigid and flat cartridge which defines three blood chambers constituted by a pre-pump
arterial blood chamber, a post-pump arterial blood chamber, and a venous chamber.
The cartridge further defines two tubular extensions for coupling the arterial pump
tract which fluidly connects the pre-pump chamber with the post-pump chamber, and
gripping organs for engaging a dialyser connected fluidly to the blood flow line.
[0012] WO 2005/044341 describes an integrated blood treatment module comprising a blood treatment device
in the form of a hollow fibre filter provided with a tubular housing rigidly connected
with two tubular extensions to which the ends of a pump tract for a peristaltic pump
are coupled. The module further comprises a venous chamber for air/blood separation.
[0013] US 2005/0230292 describes a hemodialysis cartridge with an integrated dialyser, in which the cartridge
comprises a rigid base body affording various recesses which are covered by an elastomer
sheet. These recesses, in collaboration with the elastomer covering sheet, define
blood passages, an arterial measuring chamber, and two blood pumping chambers. The
cartridge is coupled to a hemodialysis machine provided with various actuators and
sensors which interact with the elastomer sheet,
[0014] WO 03/047656 discloses a method for monitoring the supply of substitution liquid during an extracorporeal
blood treatment and to an extracorporeal blood treatment unit equipped with a device
for monitoring the supply of substitution liquid. The monitoring of the supply of
substitution liquid is based on the measurement of pressure waves, which are generated
by the substitution liquid pump, in the extracorporeal blood circulation system. A
disturbance in the supply of substitution liquid is inferred when the amplitude of
the pressure waves exceeds a predetermined limit value. The amplitude of the pressure
waves is preferably monitored in the venous blood line.
[0015] One of the problems in the prior art is that of providing a disposable fluid circuit
which is usable for performing a hemo(dia)filtration treatment with pre-dilution and/or
post-dilution and which is couplable simply, rapidly, economically and reliably to
a machine for monitoring the treatment.
SUMMARY OF THE INVENTION
[0016] An aim of the present invention is to obviate the above-mentioned drawback in the
prior art.
[0017] A further aim of the invention is to provide an apparatus which enables hemo(dia)filtration
to be performed both in pre-dilution and in post-dilution.
[0018] An advantage of the invention is that it provides a disposable apparatus for hemo(dia)
filtration which is couplable simply and rapidly to a deformed-tube type pump for
circulation of the replacement fluid.
[0019] A further advantage is to make available an apparatus which is operatively associable,
and easily so, to a device predisposed on the treatment monitoring machine in order
to monitor the replacement fluid pressure.
[0020] A still further advantage is that it gives rise to a small-volume apparatus which
is easy to handle.
[0021] These and other aims besides are all attained by the object as it is characterised
in the appended claims.
[0022] Further characteristics and advantages of the present invention will better emerge
from the detailed description that follows, of at least an embodiment of the invention,
illustrated by way of non-limiting example in the figures of the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The description will be made herein below with reference to the appended figures
of the drawings, provided by way of non-limiting example, in which:
figure 1 is a diagram of the hemo(dia)filtration apparatus;
figure 2 is a front view of an apparatus made according to the diagram of figure 1,
and applied operatively to the front panel of a machine for dialysis;
figure 3 is a perspective view from behind of the apparatus of figure 2, with some
parts removed better to evidence others;
figure 4 is a perspective view from the front of figure 3;
figure 5 is a perspective view from behind of the infusion module of the apparatus
of figure 3, with some parts removed and other parts added with respect to figure
3;
figure 6 is a view from the front of figure 5;
figure 7 is a front view of a component of the infusion module of figure 3 which includes
the blood chamber 12 in which the mixing between the blood and the infused liquid
takes place;
figure 8 is a view from behind of figure 7;
figure 9 is a view from above of figure 7;
figure 10 is a view from below of figure 7;
figure 11 is a view from the left of figure 7;
figures 12, 13, 14 and 15 are sections according respectively to lines XII, XIII,
XIV and XV of figures 7, 8 and 11.
DETAILED DESCRIPTION
[0024] With reference to figure 1, 1 denotes in its entirety an extracorporeal blood treatment
apparatus destined for coupling to a machine for extracorporeal blood treatment able
to provide a treatment fluid. In the following description the extracorporeal blood
treatment apparatus will be called a hemo(dia)filtration apparatus 1, the extracorporeal
blood treatment machine will be called a dialysis machine and the treatment fluid
will be called dialysis fluid, without any more generalised references being lost
by use of this terminology. In particular the dialysis machine produces on-line a
dialysis fluid of predetermined chemical composition (for example by mixing water
and solid and/or liquid concentrates). The dialysis machine is able to reduce the
concentration of endotoxins in the dialysis fluid (for example by passage of dialysis
fluid through one or more stages of ultrafiltration). The dialysis machine is able
to provide a control system of patient weight loss during the treatment (for example
by a control of the difference between the dialysis fluid delivery at the inlet and
outlet of the blood treatment device thanks to the use of two pumps arranged before
and after the blood treatment device - hereinafter hemo(dia)filter - and of two flow-meters
arranged before and after the hemo(dia)filter). The hemo(dia)filtration apparatus
1 can be composed, all or in part, by disposable elements. The dialysis machine (of
which the front panel is partially illustrated in figure 2) is of known type, is provided
with a fresh dialyser fluid port 2 (see the diagram of figure 1), from which the dialysis
fluid to be introduced in the hemo(dia) filter is taken, an exhausted fluid port 3,
in which the fluid exiting the hemo(dia)filter is discharged (made up of used dialysis
fluid and/or of ultrafiltrate), and an on-line port 4 from which the dialysis fluid,
to be processed for use as replacement fluid in hemo(dia)filtration treatment, is
taken. The dialysis machine is further provided with a system of known type and not
illustrated, for preparation of the dialysis fluid; this system is connected to a
main dialysis fluid supply line, which terminates in the fresh dialysate port 2. A
secondary dialysis fluid supply line, which branches from the main supply line, terminates
in the on-line port 4. The dialysis machine is further provided with an exhausted
liquid discharge line which originates at one end at the exhausted liquid port 3 and
which terminates at the other end thereof in a drainage (of known type and not illustrated).
When the hemo(dia)filtration apparatus 1 is used as a hemofiltration apparatus 1,
the fresh dialysate port 2 is closed, or non-operative, or, in a further embodiment,
absent.
[0025] The hemo(dia)filtration apparatus 1 comprises the hemo(dia)filter 5 having a blood
chamber and a fluid chamber (not illustrated) which are separated from one another
by a semipermeable membrane (not illustrated) which, in this case, comprises a bundle
of hollow fibres. In this embodiment the blood chamber comprises the space internally
of the hollow fibres, while the fluid chamber comprises the space externally of the
hollow fibres. The fluid chamber is further at least partially defined by the tubular
body containing the bundle of hollow fibres. The hemo(dia)filtration apparatus 1 comprises
an extracorporeal blood circuit having an arterial line 6, or a blood removal line
from the patient for the blood to be treated in the hemo(dia)filter 5, and a venous
line 7, or patient return line for the blood treated in the hemo(dia)filter 5. The
hemo(dia)filtration apparatus 1 further comprises a blood pump 8 for circulation of
blood in the extracorporeal circuit. The blood pump 8 is of a tube-deforming rotary
type (peristaltic). The extracorporeal blood circuit further comprises the blood chamber
of the hemo(dia)filter 5. The arterial line 6 comprises an arterial patient end 9,
a pre-pump arterial expansion chamber 10, a blood pump tube tract 11, a post-pump
arterial expansion chamber 12, an arterial device end 13. The venous line 7 comprises
a venous device end 14, a venous expansion chamber 15, a venous patient end 16. The
dialysis machine is provided with an arterial clamp 17 operating on the arterial line
6, in particular between the patient arterial end 9 and the pre-pump arterial expansion
chamber 10. The dialysis machine is provided with a venous clamp 18 operating on the
venous line 7, in particular between the patient venous end 16 and the venous expansion
chamber 15. The patient arterial end 9, like the patient venous end 16, is designed
for connection (directly or via a vascular access device of known type) with a vascular
access of a patient. The arterial clamp 17, respectively the venous clamp 18, serves
for closing a squeezable tract of the arterial line 6, respectively of the venous
line 7, on command of a control unit of the dialysis machine. The pre-pump arterial
expansion chamber 10, which is arranged downstream of the arterial clamp 17 (where
"downstream" means with reference to the blood circulation direction during the treatment),
serves for separating the air contained in the blood and for monitoring the arterial
blood pressure (before the blood pump 8). The venous expansion chamber 15, which is
arranged upstream of the venous clamp 18 (where "upstream" means with reference to
the blood circulation direction during the treatment), is for separating the air contained
in the blood and for monitoring the venous blood pressure. The pre-pump arterial expansion
chamber 10, like the venous expansion chamber 15, is designed to give rise to a liquid
level separating a lower part full of liquid (blood) from an upper part full of gas
(air). Each of the expansion chambers 10 and 15 is provided, for example superiorly,
with a zone predisposed for pressure reading; this zone comprises, in the specific
case, a membrane device, of known type, having a deformable elastic membrane with
an internal surface in contact with the fluid (blood and/or air) contained in the
chamber and an external surface operatively associable to a pressure sensor of the
dialysis machine. The blood pump tube tract 11, which is designed for removably coupling
with the blood pump 8, is open-ring conformed (in the specific embodiment it is U-shaped
with a horizontal lie and with the convexity facing right, with reference to the viewpoint
of a user situated in front of the front panel of the dialysis machine) with two ends,
one for blood inlet and the other for blood outlet, fluidly and mechanically connected
to two tubular extensions 19 (figure 2) solidly connected to the pre-pump arterial
expansion chamber 10. The arterial device end 13 and the venous device end 14 are
designed for removably coupling with an inlet port (in the specific embodiment, upper)
and, respectively, an outlet port (in the specific embodiment, lower) of the blood
chamber of the hemo(dia)filter 5. The pre-pump arterial expansion chamber 10 and the
venous expansion chamber 15 are integrated in a cartridge structure of known type.
[0026] The post-pump arterial expansion chamber 12 is inserted in the arterial line 6 between
the blood pump 8 and the hemo(dia)filter 5. The post-pump arterial expansion chamber
12 comprises a blood inlet port 20, an infusion fluid inlet port 21 (in the present
example of hemo(dia)filtration with pre-dilution, the infusion fluid, or infusate,
can be replacement fluid, or substituate; in the following description the specific
term "replacement fluid" and "substitute" will be used instead of more general terms
like "infusion fluid" and "infusate", without the generalised meaning being compromised),
a mixing zone where the blood and replacement fluid are mixed, and an outlet port
for the blood-fluid mixture 22 (where the replacement fluid is present in the mixture
in case of pre-dilution and absent in case of no pre-dilution).
[0027] The post-pump arterial expansion chamber 12 serves to separate the air contained
in the replacement fluid. The post-pump arterial expansion chamber 12 monitors the
pressure in the replacement fluid supply line. The post-pump arterial expansion chamber
12 also serves to further separate the air contained in the blood along the arterial
line 6 downstream of the blood pump 8 and for monitoring the blood pressure in the
arterial line 6 between the blood pump and the hemo(dia)filter 5. The post-pump arterial
expansion chamber 12 is designed to produce a liquid level that separates a lower
part which is full of liquid (blood or blood/replacement fluid mixture) and an upper
part which is full of gas (air). The post-pump arterial expansion chamber 12 is provided,
for example superiorly, with a zone predisposed for pressure detection; this zone
comprises, in the present embodiment, a membrane device 58, of known type, having
a deformable membrane with an internal surface in contact with the fluid containedin
the chamber and an external surface which is operatively associable to a pressure
sensor of the dialysis machine. The post-pump arterial expansion chamber 12 will be
described in greater detail herein below.
[0028] The hemo(dia)filtration apparatus 1 comprises a replacement fluid supply line 23
which provides, in this embodiment, the replacement fluid (substituate) to the extracorporeal
blood circuit. The supply line 23 takes the dialysis fluid from the on-line port 4
and, after an ultrafiltration treatment to make it suitable as a replacement fluid,
conveys it to the extracorporeal blood circuit.
[0029] The supply line 23 branches out from a main branch 24 into a pre-dilution branch
25 fluidly connected to the arterial line 6 and a post-dilution branch 26 fluidly
connected to the venous line 7. The replacement fluid supply line 23 comprises an
inlet end 27 having a connector for removable connection with the on-line port 4 for
sourcing the dialysis fluid supplied by the dialysis machine. Alternatively to an
on-line port of a machine for dialysis fluid preparation, other fluid sources can
be used, for example a ready-prepared dialysis fluid or replacement fluid recipient,
or a centralised dialysis fluid supply system, supplying to various units.
[0030] The replacement fluid supply line 23 comprises an ultrafilter 28 predisposed fluidly
in the main branch 24 upstream of the branch-out for ultrafiltering the dialysis fluid
taken from the dialysis machine to render the fluid suitable for use as a replacement
fluid. The ultrafilter 28 reduces the endotoxin percentage in the fluid. The ultrafilter
28 comprises a semipermeable membrane that separates a first chamber containing the
fluid to be ultrafiltered (dialysis fluid) from a second chamber containing the ultrafiltered
fluid (replacement fluid). The semipermeable membrane comprises, in the present embodiment,
a bundle of hollow fibres. The first chamber of the fluid to be ultrafiltered comprises
the inside of the hollow fibres, while the second chamber of the ultrafiltered fluid
is defined between the outside of the hollow fibres and the tubular body enclosing
the bundle of hollow fibres.
[0031] The ultrafilter 28 is further provided, for example superiorly, with a vent line
of the air communicating with the first chamber of the fluid to be ultrafiltered and
having a clamp (for example manually activated) for intercepting and a vent into the
atmosphere protected by a protection device (for example a hydrophobic membrane).
[0032] The replacement fluid supply line 23 can further comprise a check valve predisposed
fluidly in the main branch 24 upstream of the branch-out. The check valve, which in
the present embodiment is not present, might be located after the ultrafilter 28.
[0033] A tract of the replacement fluid pump tube 29 is predisposed in the supply line 23
for coupling with a replacement fluid circulation pump 30. In the present embodiment
the replacement fluid pump 30 is a tube-deforming rotary pump (peristaltic). The replacement
fluid pump tube tract 29 is open-ring shaped with an aspiration end and a delivery
end. In particular the replacement fluid pump tube tract 29 is U-shaped, and, in the
use configuration with the pump 30, lies on a vertical plane, with the two end branches
arranged horizontally (the convexity of the U is directed oppositely to the blood
pump tube tract 11, i.e. in the present embodiment to the left with reference to the
viewpoint of a user situated in front of the front panel of the machine). The rotation
axes of the two rotary pumps 8 and 30 are parallel to one another. The pump tube tract
29, in the engaged configuration with the pump 30, is arranged symmetrically to the
blood pump tube tract 11, with respect to a plane of symmetry (in the present embodiment,
vertical) which is parallel to the rotation axes of the two rotary pumps 8 and 30.
The replacement fluid pump tube tract 29 is fluidly arranged in the main branch 24
upstream of the branch-out (where "upstream" means in reference to the circulation
direction of the replacement fluid). The replacement fluid pump tube tract 29 is arranged
fluidly upstream of the ultrafilter 28.
[0034] The replacement fluid supply line 23 comprises an auxiliary connection 31 fluidly
arranged after the ultrafilter 28. This auxiliary connection 31 is branched out from
the replacement fluid line 23. The auxiliary line is further provided with a clamp
32 (for example a manually operated clamp) for closing the auxiliary line, and a protection
hood for removable closure of the auxiliary line 31. The auxiliary line branches off
from the main branch 24 before the branch-out.
[0035] The auxiliary connection 31 is designed for removable fluid connection with the extracorporeal
blood circuit, in particular with the arterial line 6 or the venous line 7. The auxiliary
connection 31 serves to fill the extracorporeal circuit with the replacement fluid,
in particular during the circuit priming stage, i.e. during the stage preliminary
to the treatment during which the air and any other undesirable particles contained
in the blood circuit are evacuated and the circuit is filled with an isotonic liquid,
for example a saline solution coming from a bag or, as in the present embodiment,
with an isotonic fluid (dialysis fluid or saline) which is prepared by the dialysis
machine, supplied to the on-line port 4 of the machine and ultrafiltered by crossing
the replacement fluid supply line 23. In the present embodiment the auxiliary connection
31 is removably couplable to the patient end of the arterial line 9 or to the patient
end of the venous line 16. The auxiliary connection 31 comprises, for example, a female
luer connector couplable to a male luer connector at the patient arterial 9 or venous
16 end.
[0036] At least one from among the three above-mentioned expansion chambers (arterial pre-pump
10, arterial post-pump 12 and venous 15) is fluidly connected, in particular directly,
to the pre-dilution branch 25 or the post-dilution branch 26. In the present embodiment
the post-pump arterial expansion chamber 12 is fluidly connected directly to the pre-dilution
branch 25.
[0037] The post-dilution branch 26 opens (directly) into a point of venous line 7 comprised
between the hemo(dia)filter 5 and the venous chamber 15. The venous chamber 15 therefore
indirectly communicates, via a tract of venous line 7, with the post-dilution branch
26.
[0038] The aspiration and delivery ends of the replacement fluid pump tube tract 29 are
rigidly connected to at least one from among the above-mentioned expansion chambers
(arterial pre-pump 10, arterial post-pump 12 and venous 15). In the present embodiment
the aspiration and delivery ends of the replacement fluid pump tube tract 29 are connected
rigidly to the post-pump arterial expansion chamber 12. As mentioned, the expansion
chamber bearing the replacement fluid pump tube tract 29, i.e. the chamber 12, is
provided with a zone for monitoring the pressure which is predisposed for connection
with a pressure sensor provided on the dialysis machine. This monitoring zone is provided
with the pressure detecting device 58.
[0039] Two tubular extensions for fluid and mechanical connection of the two ends of the
pump tube tract 29 are solidly connected (for example are made in a single piece with
the chamber itself) to the chamber 12. The two tubular extensions are not fluidly
connected to the chamber 12, if not indirectly through other parts (for example the
ultrafilter 28) of the fluid circuit transporting the replacement fluid.
[0040] The replacement fluid supply line 23 comprises a fluid communication system which
is interpositioned fluidly between the delivery end of the replacement fluid pump
tube tract 29 and the expansion chamber bearing the replacement fluid pump tube tract
29 (as mentioned in this case the expansion chamber bearing the pump tube tract 29
is the post-pump arterial expansion chamber 12). This fluid communication system comprises
one or more from the following elements: the ultrafilter 28, the check valve (if present),
the branch-out, and at least a tube tract which is flexible and closable by elastic
deformation, in particular squeezing.
[0041] In the present embodiment, the fluid communication system, which places the replacement
fluid pump tube tract 29 in communication with the extracorporeal blood circuit, comprises
a first flexible tube 41 having a first end connected with a first tubular connection
42 which is rigidly connected to (but not fluidly communicating with) the post-pump
arterial chamber 12 (the first tubular connection 42 is arranged inferiorly of the
chamber 12 itself), and a second end which is opposite the first end and connected
to a second tubular connection 43 for inlet of the ultrafilter 28 (the second tubular
connection 43 for inlet is located inferiorly of the ultrafilter 28 and communicates
with the chamber of the fluid to be ultrafiltered). Each of these tubular connections
42 and 43 faces downwards, with reference to an operative configuration of the apparatus
1. Each of these tubular connections 42 and 43 has a longitudinal axis which extends,
at least prevalently, in a vertical direction.
[0042] The above-described fluid communication system comprises the ultrafilter 28 and a
second three-way flexible tube 44 having a first end which is connected to a tubular
connection for for outlet of the ultrafilter 28 (the tubular outlet connection is
located on a side of the ultrafilter 28 itself, in particular superiorly, and communicates
with the ultrafiltrate fluid chamber, i.e. with the outside of the hollow fibres),
a second end (arranged superiorly and facing upwards) to which the auxiliary connection
31 is connected by means of the auxiliary line, and a third end (arranged inferiorly
and facing downwards).
[0043] The above-mentioned three ends of the second flexible tube 44 are in reciprocal fluid
communication (for example with reciprocal T or Y arrangement). The second three-way
flexible tube 44, which in the present embodiment is T-shaped with the first end arranged
at 90° to the other two, is press-formed by injection of a soft plastic material.
[0044] The fluid communication system comprises a third three-way flexible tube 45 having
a first end which is connected to the third end of the second flexible tube 44, a
second end connected to the inlet port 21 of the replacement fluid to the chamber
12, and a third end connected to a zone of the venous line 7 arranged upstream of
the venous expansion chamber 15. In the present embodiment the first end is arranged
superiorly (facing upwards), the third end is arranged inferiorly (facing downwards),
while the second end is arranged obliquely (facing upwards) with respect to the other
two, forming an angle which is less than a right-angle with the first upper end. The
third three-way flexible tube 45 is made by press-forming by injection of a soft plastic
material. The third three-way flexible tube 45 exhibits the branch-out in the pre-dilution
branches 25 and the post-dilution branches 26, which comprise two of the three ways
of the third flexible tube 45 (in particular the ways that exhibit the second and
third ends).
[0045] The hemodiafiltration apparatus 1 is made in two distinct modules which are fluidly
connected one to the other. A first module A (on the right in figure 2) comprises
an initial tract of arterial line 6 which goes from the patient arterial end 9 to
the pre-pump expansion chamber 10. The first module A further comprises the pre-pump
expansion chamber 10, the blood pump tube tract 11 and the venous expansion chamber
15 (integrated with the chamber 10 in the cartridge structure of known type). The
first module A further comprises a final tract of venous line 7 which goes from the
venous expansion chamber 15 to the patient venous end 16. The first module A also
comprises a tract of arterial line 6 which is arranged downstream of the blood pump
8 and which is integrated into the cartridge body structure. As mentioned, the cartridge
structure, which incorporates the chambers 10 and 15, supports the two ends, aspiration
and delivery, of the blood pump tube tract 11.
[0046] A second module B (on the left in figure 2) comprises the replacement fluid supply
line 23 (starting from the inlet end 27, and including the replacement fluid pump
tube tract 29, the ultrafilter 28 and the pre-dilution and post-dilution branches
25 and 26). The second module B further comprises the post-pump arterial expansion
chamber 12. Also included are an intermediate tract of arterial line 33 which fluidly
connects an arterial outlet of the first module A (connected to an outlet of the blood
pump tube tract) with an arterial inlet of the second module B (connected to the blood
inlet of the post-pump arterial expansion chamber), and an intermediate tract of venous
line 34 which fluidly connects a venous outlet of the second module B (connected with
the post-dilution branch 26) with a venous inlet of the first module A (connected
with an inlet of the venous expansion chamber).
[0047] The second module B comprises a support element to which the supply line of the replacement
fluid 23 is constrained in order that the pre-dilution 25 and post-dilution branches
25 and 26 are positioned in a prefixed position with respect to the post-pump arterial
expansion chamber. The correct and stable positioning of the pre-dilution and post-dilution
branches 25 and 26 with respect to the front panel of the dialysis machine enables
operatively efficient use of the above-said branches with two control valves, a pre-dilution
control valve 52 and a post-dilution control valve 53 arranged on the front panel.
[0048] The support element comprises, in the present embodiment, one or more extensions
35 which emerge from the expansion chamber which bears the replacement fluid pump
tube tract 29 (i.e. the post-pump arterial chamber 12). The extensions 35 emerge from
a side of the chamber 12 located on the opposite side with respect to the replacement
fluid pump tube tract 29 and extend in an opposite direction with respect to the extension
of the pump tract 29 itself The extensions 35, in the present embodiment, are rigidly
connected to the chamber 12 that bears the replacement fluid pump tube tract 29. The
extensions 35, in the present embodiment, are made (for example by press-forming of
plastic material) in a single piece with the chamber 12 itself. The support element
further comprises a casing 36 engaged to one or more of the extensions 35. The casing
36 in the present embodiment is joint-coupled to one or more of the extensions 35.
In particular the casing 36 is coupled to one or more of the extensions 35 in at least
two joint zones. The casing 36, made of plastic material, is provided with a front
part which at least partially contains the tubular body of the ultrafilter 28.
[0049] One of the extensions 35 exhibits a mounting extension 37 which, in collaboration
with the two tubular extensions 38 for engagement of the ends of the replacement fluid
pump tube tract 29, serve for removably mounting the second module B on the front
panel of the dialysis machine.
[0050] The pre-dilution 25 and post-dilution 26 branches each comprise at least a tract
of flexible tube which can be obstructed by squeezing. These tracts of flexible tube
are positioned in a prefixed position with respect to the post-pump arterial expansion
chamber 12. The correct positioning of the prefixed position is easily reached when
mounting the module B on the front panel of the machine, by virtue of the fact that
the fluid connection system formed by the second flexible tube 44 and the third flexible
tube 45 are positioned stably with respect to the support element of module B, so
that the pre-dilution 25 and post-dilution 26 branches (made from the third flexible
tube 45) are immobile with respect to the support element of module B, although each
of them is elastically deformable and therefore closable by squeezing of the valves
52 and 53.
[0051] The branch from the pre-dilution 25 and post-dilution 26 branches which is not fluidly
connected to the espansion chamber bearing the replacement fluid pump tube tract 29
can be constrained, directly or via a tract of the extracorporeal blood circuit, to
the support element. In the present embodiment, in which the expansion chamber bearing
the replacement fluid pump tube tract 29 is the post-pump expansion chamber 12 (which
chamber 12 is connected to the pre-dilution branch 25), the post-dilution branch 26
can be constrained to the support element via a tract of venous line 7 of the extracorporeal
blood circuit. In particular, a tract of venous line 7 is engaged in two recesses
afforded in the casing 36, and the post-dilution branch 26 is fluidly connected to
this tract of venous line 7.
[0052] The main branch 24 of the supply line 23 is constrained (for example directly, as
in the present embodiment) to the support element. In particular the main branch 24
exhibits at least a support zone that interacts (in a gripping and/or direct contact
coupling) with the support element in a tract that is downstream of the ultrafilter
28. In more detail, a tract of the main branch 24 arranged downstream of the ultrafilter
28 is engaged (by, for example, a removable joint) in a seating afforded on one of
the extensions 35. This tract of the main branch 24 (which in the present embodiment
is part of the second flexible tube 44) exhibits, at the ends thereof, two annular
projections which are axially distanced from one another and which are arranged externally
of the opposite ends of the seating 46, functioning as stable centring and positioning
tabs of the tract of main branch 24 in the seating 46.
[0053] The ultrafilter 28 is supportedly constrained to the support element of module B,
in particular to the casing 36.
[0054] The support element can realise at least a mechanical and not fluid interconnection
between the expansion chamber bearing the replacement fluid pump tube tract 29 (i.e.
the chamber 12) and the replacement fluid supply line 23 and/or between the expansion
chamber bearing the replacement fluid pump tube tract 29 (chamber 12) and the extracorporeal
blood circuit. A mechanical and not fluid interconnection can also be operating between
the expansion chamber 12 and the venous line 7 (or the post-dilution branch 26 or,
respectively, the arterial line 6 (or the pre-dilution branch 25).
[0055] One of these mechanical and not fluid interconnections comprises, in the present
embodiment, one of the extensions 35 in the form of an arm that emerges (on the opposite
side with respect to the replacement fluid pump tube tract 29) from the expansion
chamber 12 which bears the replacement fluid pump tube tract. As already mentioned,
this arm exhibits at an end thereof an attachment point (seating 46) for the main
branch 24 of the supply line 23. As already mentioned, the support element realises
both the mechanical and not fluid interconnection between the chamber 12 and the line
23, and the mechanical and not fluid interconnection between the chamber 12 and the
blood circuit.
[0056] The support element of the second module B comprises, in the present embodiment,
two elements which are assembled one to the other, i.e. the extensions 35 (integrated
with the chamber 12) and the protection casing 36. However it would be possible, to
have the support element made in an integrated single piece or an assembly of three
or more distinct elements.
[0057] The second module B comprises an integrated element which defines the expansion chamber
supporting the replacement fluid pump tube tract 29, i.e. the chamber 12. This integrated
element also defines a part of the support element of the second module B, in particular
the extensions 35.
[0058] The integrated element further defines a first conduit 39 for blood inlet into the
expansion chamber 12, a second conduit 50 for replacement fluid inlet, and a third
conduit 40 for blood outlet (or blood mixed with replacement fluid) from the expansion
chamber 12.
[0059] The first and third blood conduit 39 and 40 belong to the extracorporeal blood circuit
and are located on two opposite sides of the above-described expansion chamber 12
and extend in length in a vertical direction, with reference to an operative configuration
in which the pump tube tract 29 is coupled to the replacement fluid circulation pump
30.
[0060] The first and third blood conduits 39, 40 also each have a bottom end which is fluidly
connected to an expansion reservoir 47 of the post-pump arterial expansion chamber
12, and an upper end which is fluidly connected (via the ports 20 and 22) to the rest
of the arterial line 6, respectively before and after the post-pump arterial expansion
chamber 12. In particular the first inlet conduit 39 is connected to an initial part
of the arterial blood line 6 having the patient end 9 destined for connection with
the arterial vascular access; the third outlet conduit 40 is connected to a final
part of the arterial blood line 6 having the device end 13 destined for connection
to the hemo(dia)filter 5.
[0061] With reference to figures from 7 to 14, the integrated element defining the chamber
12 is described in greater detail. The chamber 12 comprises the expansion reservoir
47 which is provided with a bottom, a top, at least a first side extending between
the bottom and the top, a first access 48 arranged on the first side at a distance
from the bottom and top, and a second access 49.
[0062] The first conduit 39 terminates in the first access 48. A second conduit 50 terminates
in the first conduit 39 or, as in the present embodiment, in the expansion reservoir
47. The first conduit 39 and the second conduit 50 terminate in the first access 48
with, respectively, a first flow direction and a second flow direction which are incident
to one another.
[0063] The first conduit 39 terminates in the first access 48 with a first flow direction
having at least a motion component directed towards the bottom. The first flow direction
has at least a motion component directed towards a second side of the expansion reservoir
47; the second side extends between the bottom and top and is opposite the first side.
[0064] The second conduit 50 terminates in the expansion reservoir 47 with a second flow
direction having at least a motion component directed towards the second side of the
expansion reservoir 47. The second flow direction has at least a motion component
directed towards the top. The second flow direction has at least a first motion component
that is horizontal and directed towards the inside of the expansion reservoir 47.
[0065] The second conduit 50 comprises an intermediate tract 59 having a flow direction
provided with at least a second horizontal motion component going in an opposite direction
to the first horizontal motion component. The flow direction of the intermediate tract
59 is provided with at least a vertical motion component.
[0066] The first conduit 39 has a diverging tract 51 with a fluid passage that broadens
in the direction of the first access 48. The diverging tract 51 broadens towards the
bottom of the reservoir 47. The expansion reservoir 47 extends prevalently on a lie
plane; the diverging tract 51 enlarges prevalently in a perpendicular direction to
the lie plane. The diverging tract 51 terminates at the first access 48.
[0067] The first access 48 is elongate and extends in a perpendicular direction to the first
side of the reservoir 47.
[0068] The second access 49 is arranged on the bottom of the reservoir 47. The third conduit
40 terminates in the second access 49. The third conduit 40 extends in length by the
side of the second side of the expansion reservoir 47.
[0069] The first conduit 39 terminates in the first access 48 with a first flow direction
directed towards the second access 49. The first flow direction has at least a motion
component which is direction towards the bottom.
[0070] The second conduit 50 terminates on the first side of the expansion reservoir 47
below the end of the first conduit 39. The second conduit 50 terminates either in
the first access 48 contiguously below the end of the first conduit 39 (as in the
present embodiment), or, in a further embodiment, not illustrated, it terminates in
an intermediate access arranged between the first access 48 and the bottom of the
reservoir 47.
[0071] The expansion reservoir 47 has an upper part, comprised between the first access
48 and the top, having a greater width than a lower part comprised between the bottom
and the first access 48.
[0072] The first conduit 39 meets the second conduit 50 in a connecting zone, and joins
the connecting zone in a position above the second conduit 50.
[0073] The first conduit 39 extends lengthwise by the side of the first side of the reservoir
47. The first conduit 39 is designed to introduce the transported flow (in the present
embodiment the arterial blood) into the connecting zone with at least one motion component
directed in a downwards direction. The second conduit 50 is designed to introduce
the transported flow (in this case the replacement fluid) into the connecting zone
with at least a motion component directed upwards. The first conduit 39 and the second
conduit 50 are designed so that each of the respective transported flows is introduced
into the connecting zone with at least a horizontal motion component directed internally
of the expansion reservoir 47.
[0074] The first conduit 39 and the second conduit 50 are arranged on a same side (the first
side) of the expansion reservoir 47. The first conduit 39 is situated above the second
conduit 50.
[0075] The first side of the expansion reservoir 47 has an upper zone with a vertical inclination,
and a lower zone with an oblique inclination. The oblique lower zone of the first
side is inclined in a direction nearing the second side. This oblique inclination
determines a narrowing of the expansion reservoir 47. The zone of the second side
that is facing the oblique zone of the first side is substantially vertically oriented.
The first conduit 39 has an upper tract having a substantially vertical longitudinal
axis, and a lower tract having an oblique longitudinal axis. The oblique axis is inclined
in a direction nearing the second side of the expansion reservoir 47. The first conduit
39 terminates in the expansion reservoir 47 with an oblique inclination.
[0076] The first conduit 39 is made in a single piece with the expansion reservoir 47. The
second conduit 50 is made in a single piece with the expansion reservoir 47. The third
conduit 40 is made in a single piece with the expansion reservoir 47. The chamber
12 is realised by assembly of two half-shells. The two half-shells are obtained by
press-forming of a plastic material.
[0077] The extracorporeal blood line which includes the chamber 12 is, in the present embodiment,
the arterial line 6. The chamber 12 can, however, be associated (alternatively or
in addition to the arterial line 6) to the venous line 7. The chamber 12 in this case
would be a mixing chamber for replacement fluid (in post-dilution) for degassing and
for monitoring pressure, arranged downstream of the hemo(dia)filter; the inlet port
20 would be connected to the hemo(dia) filter 5, while the outlet port 22 would be
connected to the vascular access.
[0078] During treatment, in which the arterial line 6 and the venous line 7 are connected
to the patient, the blood pump 8 is activated, so that the blood is removed from the
patient via the arterial line 6, is sent to the hemo(dia)filter 5, and is returned
to the patient via the venous line 7. The replacement fluid pump 30 is also activated,
so that the dialysis fluid is removed from the on-line port 4 of the machine, is made
to pass first through the pump tube tract 29 and then the ultrafilter 28, and is then
sent selectively to the chamber 12 on the arterial line 6 (opening the pre-dilution
valve 52 operating on the branch 25 and closing the post-dilution valve 53 operating
on the branch 26) or to the venous line 7 (valve 52 closed and valve 53 open), or
to both (valves 52 and 53 both open).
[0079] In a case of pre-dilution, the replacement fluid flow enters the expansion reservoir
47 from below, transversally encountering the blood flow that enters the reservoir
from above. Both flows are obliquely directed, each with an inlet component into the
expansion reservoir 47 which is horizontally directed (with reference to the work
position of the chamber 12) towards the second side of the expansion reservoir 47,
and a vertical component having an opposite direction to the direction of the flow.
The meeting of the two flows causes an effective remixing between the blood and the
replacement fluid, so that the mixed liquid (blood and replacement fluid) that exits
through the third conduit 40 is homogeneously mixed.
[0080] The special conformation and arrangement of the chamber 12 enables both an effective
remixing of the blood and replacement fluid and an effective degassing of the liquids
entering the expansion reservoir 47, especially the replacement fluid, thus preventing
any air bubbles exiting through the third conduit 40.
[0081] In the absence of pre-dilution (valve 52 closed), the replacement fluid does not
reach the chamber 12, while the blood enters through the first conduit 39 and exits
through the third conduit 40; since the first conduit 39 terminates directly facing
the inlet of the third conduit 40, the turbulence created is relatively low, reducing
to a minimum the formation of foam and flow resistors, while at the same time enabling
separation of the air which may still be present in the blood.
[0082] Before the treatment is performed the circuit is primed by connecting the patient
venous end 16 to the connector 31 and the patient arterial end 9 to a discharge (for
example a collection bag or a discharge connected to the exhausted fluid circuit of
the dialysis machine). Then the clamp 32 is opened, the valves 52 and 53 are closed,
the pump 8 is activated (with the tract 29 not coupled to the pump 30) in order to
aspirate fluid from the port 4 and to circulate the fluid along the venous line 7,
the blood filter of the hemodiafilter 5, and the arterial line 6 up to the end 9.
The priming of the post-dilution branch 26 is performed by activating the pump 8,
closing the venous clamp 18 and opening the valve 53 (with the valve 52 closed), while
the priming of the pre-dilution branch 25 is done by opening the valve 52
[0083] (with the venous clamp 18 and the valve 53 closed).
[0084] In a further embodiment (not shown) the support element comprises a selector configured
to selectively squeeze the flexible tube tracts of the pre-dilution and post-dilution
branches. The selector comprises a movable (e.g. rotatable) member mounted on (e.g.
rotatably coupled to) the support element. The movable member includes a first end
and a second end and can assume at least two configurations. In a first configuration
the first end squeezes one of the flexible tube tracts and in a second configuration
the second end squeezes the other of the flexible tube tracts.
[0085] Legend
- 1.
- Hemo(dia)filtration apparatus
- 2.
- Fresh dialyser fluid port
- 3.
- Exhausted fluid port
- 4.
- On-line port
- 5.
- Hemo(dia)filter
- 6.
- Arterial line
- 7.
- Venous line
- 8.
- Blood pump
- 9.
- Patient arterial end
- 10.
- Pre-pump arterial expansion chamber
- 11.
- Blood pump tube tract
- 12.
- Post-pump arterial expansion chamber
- 13.
- Arterial device end
- 14.
- Venous device end
- 15.
- Venous expansion chamber
- 16.
- Venous patient end
- 17.
- Arterial clamp
- 18.
- Venous clamp
- 19.
- Tubular extensions connected to the chamber 10 for attachment of the blood pump tube
tract 11
- 20.
- Blood inlet port of the post-pump arterial expansion chamber 12
- 21.
- Replacement fluid inlet port of the post-pump arterial expansion chamber 12
- 22.
- Outlet port for blood(-replacement fluid) from post-pump arterial expansion chamber
12
- 23.
- Replacement fluid supply line
- 24.
- Main branch of line 23
- 25.
- Pre-dilution branch of line 23
- 26.
- Post-dilution branch of line 23
- 27.
- Inlet end of line 23
- 28.
- Ultrafilter of replacement fluid
- 29.
- Replacement fluid pump tube tract
- 30.
- Replacement fluid pump
- 31.
- Auxiliary connection of line 23 (for priming)
- 32.
- Auxiliary connection 31 intercept clamp
- 33.
- Intermediate tract of arterial line between the two modules of the hemodiafiltration
apparatus
- 34.
- Intermediate tract of venous line between the two modules of the hemodiafiltration
apparatus
- 35.
- Support extensions emerging from the post-pump arterial expansion chamber
- 36.
- Casing
- 37.
- Mounting extension
- 38.
- Tubular extensions for supporting the replacement fluid tube tract
- 39.
- First conduit for blood inlet into the post-pump arterial expansion chamber
- 40.
- Third blood outlet conduit of the post-pump arterial expansion chamber
- 41.
- First flexible tube
- 42.
- First tubular connection
- 43.
- Second tubular connection
- 44.
- Second flexible tube
- 45.
- Third flexible tube
- 46.
- Seating predisposed on the support element for fixing the main branch 24
- 47.
- Expansion reservoir
- 48.
- First access of reservoir 47
- 49.
- Second access of reservoir 47
- 50.
- Second inlet conduit of replacement fluid into the post-pump arterial expansion chamber
- 51.
- Diverging tract of the first conduit 39
- 52.
- Pre-dilution control valve
- 53.
- Post-dilution control valve
- 54.
- Connection for service line located at top of expansion reservoir 47
- 55.
- Connection for an ultrafilter vent line
- 56.
- Connection for the auxiliary line provided with the auxiliary connector 31
- 57.
- Connection for an end of the initial tract of replacement fluid line 23 having the
inlet 27 at the opposite end
- 58.
- Device for detecting pressure in the blood chamber 12
- 59.
- Intermediate tract of second conduit 50
1. A hemo(dia)filtration apparatus (1) comprising:
an extracorporeal blood circuit having an arterial line (6) and a venous line (7);
a supply line (23) of replacement fluid for the extracorporeal blood circuit, said
supply line (23) having a bifurcation which divides a main branch (24) into a pre-dilution
branch (25) fluidly connected to the arterial line (6) and a post-dilution branch
(26) fluidly connected to the venous line (7);
a pump tube tract (29) predisposed in said supply line (23) for coupling with a pump
(30) for circulation of the replacement fluid, said pump tube tract (29) being conformed
as an open ring with an aspiration end and a delivery end; and
an expansion chamber (12) predisposed in said extracorporeal blood circuit; one of
said pre-dilution branch (25) and said post-dilution branch (26) leading to said expansion
chamber (12);
characterized in that
said aspiration end and said delivery end are rigidly connected to said expansion
chamber (12); and
in that the apparatus further comprises:
a support element (35, 36) to which said supply line (23) is constrained in order
that said pre-dilution branch (25) and said post-dilution branch (26) are positioned
in a pre-determined position with respect to said expansion chamber (12), and
a module comprising said supply line (23), said pump tube tract (29), said expansion
chamber (12), and said support element (35, 36), wherein
said pre-dilution branch (25) and said post-dilution branch (26) each comprise at
least a squeezable tract of tube, said squeezable tracts of tube being positioned
in a pre-fixed position with respect to said expansion chamber (12).
2. The apparatus of claim 1, wherein the support element comprises a selector configured
to selectively squeeze said squeezable tracts of tube of said pre-dilution and post-dilution
branches (25; 26).
3. The apparatus of any one of the preceding claims, wherein said squeezable tracts of
tube form an angle greater than a right angle.
4. The apparatus of any one of the preceding claims, wherein said main branch (24) has
an end tract terminating at the bifurcation; said end tract of the main branch and
a first of said squeezable tracts of tube forming an angle smaller than a right angle,
in particular a second of said squeezable tracts of tube forming a prolongation of
said end tract of the main branch (24).
5. The apparatus of any one of the preceding claims, wherein a first of said squeezable
tracts of tube is oriented obliquely, with reference to an operative configuration
in which said pump tube tract (29) is coupled to said pump (30), and upwardly, with
reference to a flow moving from the bifurcation along said first squezzable tract
of tube.
6. The apparatus of any one of the preceding claims, wherein the one of said pre-dilution
branch (25) and post-dilution branch (26) not leading to the expansion chamber is
constrained directly or via a tract of said extracorporeal blood circuit to the support
element, said main branch (24) is for example constrained directly to said support
element (35, 36), in particular, said main branch (24) comprises an ultrafilter (28)
which is directly constrained to said support element (36).
7. The apparatus of any one of the preceding claims, comprising a check valve fluidly
predisposed in said main branch upstream of said bifurcation and wherein said pump
tube tract (29) is fluidly arranged in said main branch (24) upstream of said bifurcation.
8. The apparatus of any one of the preceding claims, wherein said expansion chamber (12)
is predisposed in said arterial line (6) and has an inlet fluidly connected to said
pre-dilution branch (25), said expansion chamber (12) being provided with a pressure
monitoring zone for connection to a pressure sensor.
9. The apparatus of any one of the preceding claims, comprising an ultrafilter (28) which
is fluidly predisposed in said main branch (24) upstream of said bifurcation, either
upstream or downsteam said pump tract (29).
10. The apparatus of any one of the preceding claims, wherein the support element (35,
36) mechanically interconnets said expansion chamber (12) and said supply line (23)
and/or said expansion chamber (12) and said extracorporeal blood circuit, said expansion
chamber (12) is for example fluidly inserted in said arterial line (6); in particular
the support element mechanically interconnects said expansion chamber (12) and said
venous line (7) or said post-dilution branch (26).
11. The apparatus of claim 10, wherein said expansion chamber (12) is fluidly inserted
in said venous line (7); the support element mechanically interconnecting said expansion
chamber (12) and the arterial line or the pre-dilution branch (25).
12. The apparatus of any one of the claims 10 or 11, comprising an ultrafilter (28) which
is fluidly predisposed in said main branch (24) upstream of said bifurcation and which
is connected in support relationship to said support element (35, 36).
13. The apparatus of any one of the claims 10 to 12, wherein the support element comprises
an arm (35) which emerges from said expansion chamber (12) and which exhibits at an
end thereof a connection with said main branch (24).
14. The apparatus of any one of the preceding claims, wherein said supply line (23) comprises
at least a system of fluid communication which is fluidly interposed between said
delivery end and said expansion chamber (12) and which is provided with one or more
of said bifurcation, an ultrafilter (28), a check valve and a squeezable tube tract.
15. The apparatus of any one of the preceding claims, comprising an integrated element
which defines said expansion chamber (12), a first blood conduit (39) and a second
blood conduit (40); said first and second blood conduits (39, 40) belonging to said
extracorporeal blood circuit; said first and second blood conduits (39, 40) each having
a lower end which is fluidly connected to said expansion chamber (12), and an upper
end which is fluidly connected to the rest of said extracorporeal blood circuit, in
particular said first blood conduit (39) being connected to an initial part of said
arterial blood line (6) having a patient end (9) which is designed to connect with
a vascular access, and said second blood conduit (40) being for example connected
to a final part of said arterial line (6) having a device end (13) designed to connect
to a hemo(dia)filter (5).
1. Hämo(dia)filtrationsvorrichtung (1) umfassend:
einen extrakorporalen Blutkreislauf mit einer arteriellen Leitung (6) und einer venösen
Leitung (7);
eine Zuführungsleitung (23) von Substitutionsfluid für den extrakorporalen Blutkreislauf,
wobei die Zugführungsleitung (23) eine Abzweigstelle besitzt, die einen Hauptzweig
(24) in einen mit der arteriellen Leitung (6) in Fluidverbindung stehenden Vorverdünnungszweig
(25) und einen mit der venösen Leitung (7) in Fluidverbindung stehenden Nachverdünnungszweig
(26) teilt;
einen Pumprohrabschnitt (29), der in der Zuführungsleitung (23) zur Kopplung mit einer
Pumpe (30) zum Zirkulieren des Substitutionsfluids vorgesehen ist, wobei der Pumprohrabschnitt
(29) als offener Ring mit einem Ansaugende und einem Abgabeende ausgebildet ist; und
eine Expansionskammer (12), die im extrakorporalen Blutkreislauf vorgesehen ist;
wobei einer des Vorverdünnungszweiges (25) und des Nachverdünnungszweiges (26) zur
Expansionskammer (12) führt;
dadurch gekennzeichnet, dass
das Ansaugende und das Abgabeende mit der Expansionskammer (12) steif verbunden sind;
und dass die Vorrichtung weiter umfasst:
ein Tragelement (35, 36), mit dem die Zuführungsleitung (23) fest verbunden ist, so
dass der Vorverdünnungszweig (25) und der Nachverdünnungszweig (26) in einer vorbestimmten
Stellung gegenüber der Expansionskammer (12) angeordnet sind, und
ein Modul umfassend die Zuführungsleitung (23), den Pumprohrabschnitt (29), die Expansionskammer
(12) und das Tragelement (35, 36), wobei
der Vorverdünnungszweig (25) und der Nachverdünnungszweig (26) jeder mindestens einen
quetschbaren Rohrabschnitt umfassen, wobei die quetschbaren Rohrabschnitte in Bezug
auf die Expansionskammer (12) in einer im Voraus festgelegten Position angeordnet
sind.
2. Vorrichtung nach Anspruch 1, wobei das Tragelement einen Wahlschalter umfasst, der
zum wahlweisen Quetschen der quetschbaren Rohrabschnitte der Vorverdünnungs- und Nachverdünnungszweige
(25; 26) konfiguriert ist.
3. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei die quetschbaren Rohrabschnitte
einen Winkel bilden, der größer als ein rechter Winkel ist.
4. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei der Hauptzweig (24) einen
an der Abzweigstelle endenden Endabschnitt aufweist; wobei der Endabschnitt des Hauptzweigs
und ein erster der quetschbaren Rohrabschnitte einen Winkel bilden, der kleiner als
ein rechter Winkel ist, wobei insbesondere ein zweiter der quetschbaren Rohrabschnitte
eine Verlängerung des Endabschnitts des Hauptzweigs (24) bildet.
5. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei ein erster der quetschbaren
Rohrabschnitte schräg ausgerichtet ist gegenüber einer Arbeitskonfiguration, bei der
der Pumprohrabschnitt (29) mit der Pumpe (30) gekoppelt ist und nach oben gegenüber
einer Strömung, die sich von der Abzweigstelle entlang dem ersten quetschbaren Rohrabschnitt
bewegt.
6. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei der eine des Vorverdünnungszweiges
(25) und des Nachverdünnungszweiges (26), der nicht zur Expansionskammer (12) führt,
unmittelbar oder durch einen Abschnitt des extrakorporalen Blutkreislauf mit dem Tragelement
fest verbunden ist, wobei der Hauptzweig (24) zum Beispiel unmittelbar mit dem Tragelement
(35, 36) fest verbunden ist, wobei insbesondere der Hauptzweig (24) einen Ultrafilter
(28) umfasst, der unmittelbar mit dem Tragelement (36) fest verbunden ist.
7. Vorrichtung nach einem der vorhergehenden Ansprüche, umfassend ein Rückschlagventil,
das im Hauptzweig stromaufwärts von der Abzweigstelle in Fluidverbindung vorgesehen
ist, und wobei der Pumprohrabschnitt (29) im Hauptzweig (24) stromaufwärts von der
Abzweigstelle in Fluidverbindung angeordnet ist.
8. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei die Expansionskammer (12)
in der arteriellen Leitung (6) vorgesehen ist und einen Eingang besitzt, der mit dem
Vorverdünnungszweig (25) in Fluidverbindung steht, wobei die Expansionskammer (12)
mit einem Drucküberwachungsbereich zur Verbindung mit einem Drucksensor ausgestattet
ist.
9. Vorrichtung nach einem der vorhergehenden Ansprüche, umfassend einen Ultrafilter (28)
der im Hauptzweig (24) stromaufwärts von der Abzweigstelle in Fluidverbindung vorgesehen
ist, entweder stromaufwärts oder stromabwärts vom Pumpabschnitt (29).
10. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei das Tragelement (35, 36)
die Expansionskammer (12) und die Zuführungsleitung (23) und/oder die Expansionskammer
(12) und den extrakorporalen Blutkreislauf mechanisch verbindet, wobei die Expansionskammer
(12) zum Beispiel in der arteriellen Leitung (6) in Fluidverbindung eingesetzt ist;
wobei insbesondere das Tragelement die Expansionskammer (12) und die venöse Leitung
(7) oder den Nachverdünnungszweig (26) mechanisch verbindet.
11. Vorrichtung nach Anspruch 10, wobei die Expansionskammer (12) in der venösen Leitung
(7) in Fluidverbindung eingesetzt ist; wobei das Tragelement die Expansionskammer
(12) und die arterielle Leitung oder den Vorverdünnungszweig (25) mechanisch verbindet.
12. Vorrichtung nach einem der Ansprüche 10 oder 11, umfassend einen Ultrafilter (28)
der im Hauptzweig (24) stromaufwärts von der Abzweigstelle in Fluidverbindung vorgesehen
ist und mit dem Tragelement (35, 36) in tragender Verbindung steht.
13. Vorrichtung nach einem der Ansprüche 10 bis 12, wobei das Tragelement einen Arm (35)
umfasst, der von der Expansionskammer (12) herausragt und an einem Ende davon eine
Verbindung mit dem Hauptzweig (24) besitzt.
14. Vorrichtung nach einem der vorhergehenden Ansprüche, wobei die Zuführungsleitung (23)
mindestens ein Fluidkommunikationssystem umfasst, das zwischen dem Abgabeende und
der Expansionskammer (12) in Fluidverbindung zwischenliegt und mit einem oder mehreren
der Abzweigstelle, des Ultrafilters (28), des Rückschlagventils und des quetschbaren
Rohrabschnitts ausgestattet ist.
15. Vorrichtung nach einem der vorhergehenden Ansprüche, umfassend ein integriertes Element,
das die Expansionskammer (12), eine erste Blutleitung (39) und eine zweite Blutleitung
(40) definiert; wobei die ersten und zweiten Blutleitungen (39, 40) zum extrakorporalen
Blutkreislauf gehören; wobei die ersten und zweiten Blutleitungen (39, 40) jede ein
unteres Ende, das mit der Expansionskammer (12) in Fluidverbindung steht, und ein
oberes Ende, das mit dem restlichen extrakorporalen Blutkreislauf in Fluidverbindung
steht, besitzen, wobei insbesondere die erste Blutleitung (39) mit einem Anfangsabschnitt
der arteriellen Blutleitung (6) mit einem Patientenende (9) zur Verbindung mit einem
Gefäßzugang verbunden ist, und wobei die zweite Blutleitung (40) zum Beispiel mit
einem Endabschnitt der arteriellen Leitung (6) mit einem Vorrichtungsende (13) zur
Verbindung mit einem Hämo(dia)filter verbunden ist.
1. Appareil pour hémo(dia)filtration (1) comprenant:
un circuit extracorporel du sang ayant une ligne artérielle (6) et une ligne veineuse
(7);
une ligne d'alimentation (23) de fluide de remplacement pour le circuit extracorporel
du sang, ladite ligne d'alimentation (23) ayant une bifurcation qui partage la branche
principale (24) dans une branche de pré-dilution (25) en connexion fluidique avec
la ligne artérielle (6) et une branche de post-dilution (26) en connexion fluidique
avec la ligne veineuse (7);
une portion de tuyau de pompe (29) prévue dans ladite ligne d'alimentation (23) pour
l'accouplement avec une pompe (30) pour la circulation du fluide de remplacement,
ladite portion de tuyau de pompe (29) étant configurée comme une bague ouverte avec
une extrémité d'aspiration et une extrémité de refoulement; et
une chambre de détente (12) prévue dans ledit circuit extracorporel du sang; l'une
entre ladite branche de pré-dilution (25) et ladite branche de post-dilution (26)
conduisant à ladite chambre de détente (12);
caractérisé en ce que
ladite extrémité d'aspiration et ladite extrémité de refoulement sont relié rigidement
à ladite chambre de détente (12); et
en ce que l'appareil comprend en outre:
un élément de support (35, 36) auquel ladite ligne d'alimentation (23) est engagée,
de sorte que ladite branche de pré-dilution (25) et ladite branche de post-dilution
(26) se trouvent dans une position préétablie par rapport à ladite chambre de détente
(12), et
un module comprenant ladite ligne d'alimentation (23), ladite portion de tuyau de
pompe (29), ladite chambre de détente (12) et ledit élément de support (35, 36), où
ladite branche de pré-dilution (25) et ladite branche de post-dilution (26) comprennent
chacune au moins une portion de tuyau compressible, lesdites portions de tuyau compressibles
étant dans une position préétablie par rapport à ladite chambre de détente (12).
2. Appareil selon la revendication 1, où l'élément de support comprend un sélecteur configuré
pour presser de façon sélective lesdites portions de tuyau compressibles desdites
branches de pré-dilution et de post-dilution (25; 26).
3. Appareil selon une quelconque des revendications précédentes, où lesdites portions
de tuyau compressibles forment un angle supérieur à un angle droit.
4. Appareil selon une quelconque des revendications précédentes, où ladite branche principale
(24) présente une portion terminale terminant à la bifurcation; ladite portion terminale
de la branche principale et une première desdites portions de tuyau compressibles
formant un angle inférieur à un angle droit, en particulier une deuxième desdites
portions de tuyau compressibles formant un prolongement de ladite portion terminale
de la branche principale (24).
5. Appareil selon une quelconque des revendications précédentes, où une première desdites
portions de tuyau compressibles est orientée obliquement par rapport à une configuration
opérationnelle dans laquelle ladite portion de tuyau de pompe (29) est accouplée avec
ladite pompe (30) et vers le haut par rapport à un flux se déplaçant de la bifurcation
le long de la première portion de tuyau compressible.
6. Appareil selon une quelconque des revendications précédentes, où l'une desdites branche
de pré-dilution (25) et branche de post-dilution (26) qui ne conduit pas à la chambre
de détente est engagée directement ou par une portion dudit circuit extracorporel
du sang à l'élément de support, ladite branche principal (24) est par exemple engagée
directement au dit élément de support (35, 36), en particulier ladite branche principale
(24) comprenant un ultrafiltre (28) engagé directement audit élément de support (36).
7. Appareil selon une quelconque des revendications précédentes, comprenant une soupape
de non-retour prévue de façon fluidique dans ladite branche principale en amont de
ladite bifurcation, et où ladite portion de tuyau de pompe (29) est rangée de façon
fluidique dans ladite branche principal (24) en amont de ladite bifurcation.
8. Appareil selon une quelconque des revendications précédentes, où ladite chambre de
détente (12) est prévue dans ladite ligne artérielle (6) et a une entrée en connexion
fluidique avec ladite branche de pré-dilution (25), ladite chambre de détente (12)
étant pourvue d'une zone de contrôle de la pression pour la connexion à un capteur
de pression.
9. Appareil selon une quelconque des revendications précédentes, comprenant un ultrafiltre
(28) prévu de façon fluidique dans ladite branche principale (24) en amont de ladite
bifurcation, en amont ou en aval de ladite portion de pompe (29).
10. Appareil selon une quelconque des revendications précédentes, où l'élément de support
(35, 36) relie mécaniquement ladite chambre de détente (12) et ladite ligne d'alimentation
(23) et/ou ladite chambre de détente (12) et ledit circuit extracorporel du sang,
ladite chambre de détente (12) est par exemple introduite de façon fluidique dans
ladite ligne artérielle (6); en particulier l'élément de support reliant mécaniquement
ladite chambre de détente (12) et ladite ligne veineuse (7) ou ladite branche de post-dilution
(26).
11. Appareil selon la revendication 10, où ladite chambre de détente (12) est introduite
de façon fluidique dans ladite ligne veineuse (7); l'élément de support reliant mécaniquement
ladite chambre de détente (12) et la ligne artérielle ou la branche de pré-dilution
(25).
12. Appareil selon une quelconque des revendications 10 ou 11, comprenant un ultrafiltre
(28) prévu de façon fluidique dans ladite branche principale (24) en amont de ladite
bifurcation et relié en relation de support avec ledit élément de support (35, 36).
13. Appareil selon une quelconque des revendications 10 à 12, où l'élément de support
comprend un bras (35) saillant de ladite chambre de détente (12) et ayant à une extrémité
une liaison avec ladite branche principale (24).
14. Appareil selon une quelconque des revendications précédentes, où ladite ligne d'alimentation
(23) comprend au moins un système de communication de fluide placé de façon fluidique
entre ladite extrémité de refoulement et ladite chambre de détente (12) et pourvu
d'un ou plusieurs desdits bifurcation, ultrafiltre (28), soupape de non-retour et
portion de tuyau compressible.
15. Appareil selon une quelconque des revendications précédentes, comprenant un élément
intégré définissant ladite chambre de détente (12), un premier conduit du sang (39)
et un deuxième conduit du sang (40); lesdits premier et deuxième conduits du sang
(39, 40) faisant partie dudit circuit extracorporel du sang; lesdits premier et deuxième
conduits du sang (39, 40) ayant chacun une extrémité inférieure en connexion de fluide
avec ladite chambre de détente (12), et une extrémité supérieure en connexion de fluide
avec le reste dudit circuit extracorporel du sang, en particulier ledit premier conduit
du sang (39) étant relié à une portion initiale de ladite ligne du sang artérielle
(6) ayant une extrémité patient (9) apte à être reliée à un accès vasculaire, et ledit
deuxième conduit du sang (40) étant par exemple relié à une portion finale de ladite
ligne artérielle (6) ayant un dispositif terminal (13) apte à être reliée à un hémo(dia)filtre
(5).